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MEDTECH Comparing the efficacy and safety of reteplase and alteplase for early reperfusion in acute ischemic stroke may reveal implications for thrombolytic therapy protocols.
This study investigates the efficacy and safety of reteplase compared to alteplase in patients with acute ischemic stroke treated within 4.5 hours of symptom onset. The primary goal was to determine if reteplase could offer a superior or noninferior functional outcome and assess its safety profile in terms of intracranial hemorrhage and adverse events.
Study Design:
- Randomized controlled trial with 1,412 patients with acute ischemic stroke.
- Patients were treated within 4.5 hours of symptom onset.
- Participants were divided into two groups: 707 received reteplase and 705 received alteplase.
- Reteplase was administered as a bolus of 18 mg followed by a second bolus of 18 mg 30 minutes later.
- Alteplase was given at 0.9 mg per kilogram of body weight, with a maximum dose of 90 mg.
- Primary efficacy outcome: excellent functional outcome (modified Rankin scale score of 0 or 1 at 90 days).
- Primary safety outcome: symptomatic intracranial hemorrhage within 36 hours after symptom onset.
Key Findings:
- Excellent functional outcome achieved in 79.5% of patients in the reteplase group compared to 70.4% in the alteplase group (risk ratio 1.13; 95% CI, 1.05 to 1.21; P<0.001 for noninferiority and P=0.002 for superiority).
- Symptomatic intracranial hemorrhage within 36 hours occurred in 2.4% of the reteplase group and 2.0% of the alteplase group (risk ratio 1.21; 95% CI, 0.54 to 2.75).
- Any intracranial hemorrhage at 90 days was higher in the reteplase group (7.7%) compared to the alteplase group (4.9%) (risk ratio 1.59; 95% CI, 1.00 to 2.51).
- Adverse events were more frequent in the reteplase group (91.6%) than in the alteplase group (82.4%) (risk ratio 1.11; 95% CI, 1.03 to 1.20).
HCN Medical Memo
This study suggests that reteplase may offer better functional outcomes for acute ischemic stroke patients treated within 4.5 hours of symptom onset compared to alteplase. However, the increased risk of intracranial hemorrhage and adverse events must be weighed when considering thrombolytic therapy options.
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